BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712NAB PRDGM INSULIN BL EN

    MDR report key: 1180057 · Received September 26, 2008

    Report

    Report Number
    2032227-2008-01674
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 16, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 749MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY WHEN BOLUSING. THE CUSTOMER STATED THAT SHE DID NOT CHANGE THE INFUSION SET AND KEPT BOLUSING. THE HIGH BLOOD GLUCOSE WAS TREATED WITH INSULIN DRIP AND HER GLUCOSE LEVEL WENT DOWN. THE CUSTOMER STATED SHE NOTICED THAT THE CANNULA WAS CURVED UPON REMOVAL AT TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712NAB PRDGM INSULIN BL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization